CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)

Aberrometer, Ophthalmic

ALCON LABORATORIES, INC.

The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Customcornea Measurement Device (ccmd).

Pre-market Notification Details

Device IDK000637
510k NumberK000637
Device Name:CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)
ClassificationAberrometer, Ophthalmic
Applicant ALCON LABORATORIES, INC. 2800 DISCOVERY DR., Orlando,  FL  32826 -3714
ContactS.k. Mcgarvey
CorrespondentS.k. Mcgarvey
ALCON LABORATORIES, INC. 2800 DISCOVERY DR., Orlando,  FL  32826 -3714
Product CodeNCF  
CFR Regulation Number886.1760 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-25
Decision Date2000-05-19

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